I received an email today that some insurance plans are requiring certain generic medications to be dispensed in short cycles because the NDC was tied to an NDA instead of an ANDA. This is something that I had never even heard of being a possibility. Is CMS aware of this? Was it intended? How on earth are we supposed to comply with the short cycle dispensing rules if there are also some generics that must be dispensed in short cycle depending on what type of paperwork was filed for their FDA approval?
Yes, because many generic products are "authorized generics" made by the company that has the NDA and put into another bottle with a new NDC#s. For example, alprazolam tablets by Greenstone are actually Xanax made by Pfizer but put in a different bottle.
The second category are drugs approved before the Hatch-Waxman Act including drugs such as potassium chloride, levothyroxine, and furosemide. Manufacturers had to get an NDA approved before they could market these products because they were originally grandfathered by the FDA for approval.
CMS is aware of this and is trying to get the FDA to mark the pre-Hatch-Waxman products with a new designation so they are not included on this list. However, they have stated that authorized generics have an NDA and therefore meet the criteria as a brand drug.
Stay tuned!!! They could change their minds again.
Just ran into this insanity on a prenatal vitamin for an ambulatory patient. Their insurance treats it as brand, even though the wholesaler and First Databank treat it as a generic. Same logic, or lack thereof.